Raman spectroscopy: a novel experimental approach to evaluating renal tumours.

BACKGROUND: New optical techniques of spectroscopy have shown promising results in the evaluation of solid tumours. OBJECTIVE: To evaluate the potential of Raman spectroscopy (RS) to assess renal tumours at surgery. DESIGN, SETTING, AND PARTICIPANTS: Over a 5-mo period, Raman optical spectra were prospectively acquired on surgical renal specimens removed due to suspicion of cancer. MEASUREMENTS: Raman measures were normalised to ensure comparison between spectra. A lower resolution signal was computed using a wavelet decomposition procedure to diminish the size of the signal and exploit the complete spectrum. A support vector machine (SVM) with a linear kernel and a sequential minimal optimisation solver was applied. A leave-one-out cross-validation technique was used to train and test the SVM. RESULTS AND LIMITATIONS: There were 36 patients with 34 malignant tumours (27 clear-cell, 6 papillary, and 1 chromophobe) and 2 benign (1 oncocytoma and 1 metanephric cyst) tumours. A total of 241 analysable Raman spectra were obtained. The SVM was able to classify tumoural and normal tissue with an accuracy of 84% (sensitivity 82%, specificity 87%). High-grade and low-grade tumours were differentiated with a precision of 82% (sensitivity 84%, specificity 80%). Histologic subtype could be categorised with an accuracy of 93% (sensitivity 96%, specificity 87%). SVM could not be applied to classify benign and malignant tumours because of the restricted number of benign spectra. CONCLUSIONS: RS can accurately differentiate normal and tumoural renal tissue, low-grade and high-grade renal tumours, and histologic subtype of renal cell carcinoma. Larger prospective studies are needed to confirm these preliminary data.

Adverse events associated with rofecoxib therapy: results of a large study in community-derived osteoarthritic patients.

OBJECTIVE: To evaluate the safety profile of rofecoxib, a selective cyclo-oxygenase-2 inhibitor, in patients with osteoarthritis who are receiving care in non-hospital practice settings. DESIGN: All patients participating in a large 24-week, open-label, nonpharmacological intervention trial were given rofecoxib for painful osteoarthritis of the knee or hip. They started at a dose of 12.5mg once daily for the first month, with the option of increasing to 25mg daily thereafter, if needed for efficacy. Adverse events were closely monitored. We considered all adverse events that occurred during treatment and within 14 days of discontinuation of rofecoxib. PATIENT GROUP STUDIED: 2896 patients (861 males and 2035 females) were involved in the safety analysis. Their mean (SD) age was 66.8 (9.9) years, and 631 patients (21.8%) were aged >/=75 years. There were 913 patients (31.5%) with hypertension and 151 (5.2%) with diabetes mellitus at the start of the study; 78 patients (2.7%) had a prior medical history of angina and/or myocardial infarction. The mean (SD) duration of rofecoxib treatment was 139 (62) days. RESULTS: A total of 519 patients (17.9%) discontinued rofecoxib. The main reasons for discontinuation were dyspepsia (4.4%), nausea (2.4%) and dizziness (2.1%). The annualised incidence rates (95% CI) of complicated and uncomplicated upper gastrointestinal ulcers, myocardial infarction, and stroke were 1.36 (0.76-2.23), 0.09 (0-0.50) and 0.45 (0.16-1.05), respectively. CONCLUSION: This study conducted in conditions close to daily practice confirms that the use of rofecoxib is associated with a low rate of serious adverse events in patients with osteoarthritis.

Bed rest or normal activity for patients with acute low back pain: a randomized controlled trial.

BACKGROUND: The management of common low back pain has two principal objectives: to relieve acute pain and to attempt prevention of transition to chronicity. Several studies have shown the ineffectiveness of prolonged periods of bed rest. OBJECTIVE: To compare 4 days of bed rest with continued normal daily activity in acute low back pain, taking into account the type of work (physical or sedentary labor). METHODS: This open, comparative multicenter study enrolled 281 ambulatory patients, ages 18 to 65 years, with low back pain (onset < 72 hours). The subjects did not have pain radiating below the buttocks and did not have work-related injuries. They were randomized into two treatment groups: one instructed to continue normal activity (insofar as the pain allowed), and the other prescribed 4 days of bed rest. After inclusion, patients were seen at three visits: on day 6 or 7, after 1 month, and after 3 months. RESULTS: On day 6 or 7, pain intensity was similar for both groups, as was the overall judgment of the treatment by patients and physicians. At 1 and 3 months, the groups again had equivalent intensity of back pain, functional disability, and vertebral stiffness. A higher proportion of patients in the bed rest group than in the normal activity group had an initial sick leave (86% vs 52%; P < 0.0001). This difference was greater for the patients whose work was sedentary. CONCLUSIONS: For patients with acute low back pain, normal activity is at least equivalent to bed rest. The findings of this study indicate that prescriptions for bed rest, and thus for sick leaves, should be limited when the physical demands of the job are similar to those for daily life activities.